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Descartes-25 in Relapsed/Refractory Multiple Myeloma

Primary Purpose

Multiple Myeloma, Relapse Multiple Myeloma

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Descartes-25

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring myeloma, multiple myeloma, Relapse Refactory multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years and older'
diagnosed with active R/RMM, who have failed 2 lines of treatment
have measurable disease

Exclusion Criteria:

- Patients with active plasma cell leukemia

Sites / Locations

Louisiana State University Health Science Center at ShreveportRecruiting
Center for Cancer and Blood DisordersRecruiting
Saglik Bilimleri UniversitesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm 1: Dose Level 1

Arm 2: Dose Level 2

Arm 3: Dose Level 3

Arm 4: Dose Expansion

Arm Description

Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached.

In Arm 2, the MTD established in Arm 1 will be administered for 3 28-day cycles to further evaluate the product's safety and preliminary efficacy.

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose

Dose Level at which no more than 20% of the patients treated have shown Dose-Limiting Toxicity.

Secondary Outcome Measures

Full Information

NCT ID

NCT05113342

First Posted

October 19, 2021

Last Updated

February 7, 2023

Sponsor

Cartesian Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT05113342

Brief Title

Descartes-25 in Relapsed/Refractory Multiple Myeloma

Official Title

Phase I/IIa Study of Descartes-25 in Patients With Relapsed/Refractory Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 25, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cartesian Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a Phase I/IIa dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of an allogeneic Mesenchymal Stem Cell (Descartes-25) product secreting a bispecific protein and other proteins in patients with Relapsed/Refractory Multiple Myeloma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma, Relapse Multiple Myeloma

Keywords

myeloma, multiple myeloma, Relapse Refactory multiple myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Dose Level 1

Arm Type

Experimental

Arm Description

Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached.

Arm Title

Arm 2: Dose Level 2

Arm Type

Experimental

Arm Description

Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached.

Arm Title

Arm 3: Dose Level 3

Arm Type

Experimental

Arm Description

Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached.

Arm Title

Arm 4: Dose Expansion

Arm Type

Experimental

Arm Description

In Arm 2, the MTD established in Arm 1 will be administered for 3 28-day cycles to further evaluate the product's safety and preliminary efficacy.

Intervention Type

Drug

Intervention Name(s)

Descartes-25

Other Intervention Name(s)

DC-25

Intervention Description

allogeneic Mesenchymal Stem Cell product.

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose

Description

Dose Level at which no more than 20% of the patients treated have shown Dose-Limiting Toxicity.

Time Frame

1 Year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years and older' diagnosed with active R/RMM, who have failed 2 lines of treatment have measurable disease Exclusion Criteria: - Patients with active plasma cell leukemia

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hafsa Kamboh, MD

Phone

3013488698

Hafsa@cartesiantx.com

First Name & Middle Initial & Last Name or Official Title & Degree

Milos Miljkovic, MD, MS

milos@cartesiantx.com

Facility Information:

Facility Name

Louisiana State University Health Science Center at Shreveport

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71103

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tamna Wangjam, M.D.

Facility Name

Center for Cancer and Blood Disorders

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Investigator

Facility Name

Saglik Bilimleri Universitesi

City

Ankara

State/Province

Anatolia

ZIP/Postal Code

06200

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fevzi Altuntas, MD

12. IPD Sharing Statement

Learn more about this trial

Descartes-25 in Relapsed/Refractory Multiple Myeloma

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